CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 16 enrolled
Drug / intervention
Zongertinib +1 moredrug
Likely dose
Zongertinib 60 milligramsfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06028464
NCT06028464Phase 1Completed
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The Effect of Multiple Doses of Carbamazepine on the Pharmacokinetics of a Single Oral Dose of BI 1810631 in Healthy Male Subjects (an Open-label, Two-period, Fixed-sequence Trial)

Boehringer Ingelheim·interventional·Posted Sep 8, 2023·Updated Nov 5, 2025

In Brief

A Phase 1 clinical trial evaluating Zongertinib and Carbamazepine for Healthy. Completed, enrolled 16 participants across 1 site.

Detailed Summary

The main objective of this trial is to investigate the effect of multiple oral doses of the strong CYP3A inducer carbamazepine on the pharmacokinetics of a single dose of BI 1810631 in plasma.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesGermany
Collaborators--

Timeline

Phase 1CompletedFinished
202420252026
First PostedSep 8, 2023
Enrollment StartSep 11, 2023
Primary CompletionDec 8, 2023
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 2.8 years ago

Interventions

Zongertinibdrug

Participants were administered a single dose of 60 milligrams (mg) of Zongertinib film-coated tablet orally on Day 1 with 240 milliliters (mL) of water after an overnight fast of at least 10 hours.

Carbamazepinedrug

Participants received increasing doses of Carbamazepine once daily as extended-release tablets with 240 mL of water for 18 days, starting at 200 mg, then 400 mg, and finally 600 mg. Afterward, they continued taking 600 mg of Carbamazepine once daily for 6 days.